QA Lead Person

Becton Dickinson Medical Devices•Sumter, SC

8d•Onsite

About The Position

Job Description Summary Manages staff roster to ensure trained inspectors are available for inspection duties in each operations department on their shift. Leads activities of the in-process quality inspection process for the plant. Ensures that Inspectors are adequately trained and that manufactured product is inspected and conforms to defined product specifications. Coordinates and guides the activities of in-process Inspectors on a daily basis. Trains and coaches associates in the performance of their responsibilities focusing on safety and conformance to BD requirements. Assures appropriate coverage to support production and plant validation efforts. Coordinates QA Floater and inspector personnel to conduct containment activities and blocked stock inspections to support control of defective materials and prevent escape. Works with Production to resolve all quality issues on their shift and in support of other shifts. Ensures that quality issues are properly segregated, investigated and dispositioned according to BD procedures and policies. Support continuous manufacturing operations by working with shift QA Leads to ensure staffing is maintained throughout the calendar month by planning and communicating coverage needs across all shifts. Escalates support or quality needs to management team as issues arise that require management support. Complete administrative requirements as deemed necessary; i.e., attendance exception reports and special projects. Schedules overtime as required. Writes reports, turns in all waste reports from previous day. Completes paperwork for the appropriate departments. Supplies all necessary documents/paperwork for inspections to Quality Associates. Processes the release of production materials in a timely manner following best practices for product control. Responsible for ensuring that Device History Records are reviewed for accuracy and completeness prior to final disposition. The QA Lead person may make final disposition on the Notification Systems. Coordinates systems and procedure changes as authorized by QA Management. Identifies and reports quality trends and issues that affect product quality by monitoring waste and internal non-conformances. Interfaces with other functions as appropriate to achieve quality improvement. Reports directly to the Quality Manager. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. Shift: This is a Night Shift role, starting from 8 pm to 8 am, alternating 48/36 hours each week.

Requirements

High School Diploma or GED
SAP experience a plus
Experience in Quality and Medical Devices a plus
Versatile and a self-starter preferred

Responsibilities

Coordinates and guides the activities of in-process Inspectors daily.
Assures appropriate coverage to support production and plant validation efforts.
Trains and coaches associates in the performance of their responsibilities focusing on safety and conformance to BD requirements.
Complete administrative requirements as deemed necessary, i.e., attendance exception reports and special projects.
Schedules overtime as required.
Write reports and completes paperwork for the appropriate departments.
Supplies all necessary documents/paperwork for inspections to Quality Associates.
Provides input and makes recommendations associated with quality inspectors related to selection, promotion, transfer, disciplinary actions or discharge as necessary.
Identifies and reports quality issues that affect product quality by monitoring internal non-conformances.
Works with other functions as appropriate to achieve quality improvement.
Responsible for ensuring that Device History Records are reviewed for accuracy and completeness prior to final disposition where applicable.
The QA Lead person may make final disposition on the Notification Systems.
Is accountable for promoting Quality on all shifts.
Works with Production as a teammate to resolve all quality issues
May assist in audits as needed.
Holds meetings with Associates to stress quality awareness, QSRs, product quality trends, changes, etc.
Operates within the Safety and QSR guidelines of the Sumter plant.
Performs all other duties as directed by Quality Management.